The Food and Drug Administration Monday unveiled the details of a new policy designed to make it easier and quicker for patients with very rare diseases to get cutting-edge treatments. The new ...

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

Jason Mast is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people that decide whether that science ever reaches patients. You can reach Jason ...

Can you design a mechanism that will trace out the shape of a heart? How about the shape of a moon, or a star? Mechanism design—the art of assembling linkages and joints to create machines with ...

Despite decades of research, the mechanisms behind fast flashes of insight that change how a person perceives their world, termed "one-shot learning," have remained unknown. A mysterious type of ...

Panelists discuss how the muscarinic pathway of xanomeline/trospium offers a safer, nondopaminergic approach to schizophrenia care. Panelists discuss how xanomeline/trospium chloride introduces a ...

The first step in a 12-step program is for the addict to admit that they have a problem, because most addicts are in denial about their addictions. And, as my clinical supervisor observed when I was ...

The US Food and Drug Administration (FDA) is proposing a new “plausible mechanism” pathway that will enable the limited approval of bespoke therapies when randomized trials are impractical. FDA will ...

In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory pathway that could trigger a seismic shift in how bespoke gene editing therapies ...

CHICAGO -- A series of large, real-world analyses supported benefit of GLP-1 receptor agonists in cardiopulmonary indications for patients with type 2 diabetes, researchers reported at the CHEST ...